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Use of Antagonist Versus Agonist GnRH in Oocyte Recipient Endometrium Preparation
This study is currently recruiting participants.
Verified by Instituto Valenciano de Infertilidad, Spain, February 2008
First Received: February 21, 2008   Last Updated: March 10, 2008   History of Changes
Sponsored by: Instituto Valenciano de Infertilidad, Spain
Information provided by: Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier: NCT00633347
  Purpose

Oocyte donation is a well established procedure in assisted reproduction treatments (ART). It is demonstrated that the use of hormonal substitution therapy, for the synchronization of the cycles between the recipients and the donors, provides good results, similar to the ones obtained with the natural cycle. In the patients - recipients with preserved ovarian function, the recipient's natural cycle is annulled, thus preventing the spontaneous Luteinizing Hormone surge. Simultaneously and while waiting for the suitable donor, her endometrium is prepared. When the donation occurs and fertilization with the husband sperm takes place, her cycle is stimulated again in order to synchronize her window of implantation with the donor's ovulation.

Two different medications are commonly used to inhibit spontaneous ovulation: either GnRHa agonist or GnRH antagonists. The present study consists of the comparison between the single dose GnRH agonist (Decapeptyl 3,75 IM) and the 7 day dosage of GnRH antagonist (Cetrotide 0,25 mg). The administration of GnRHa is used fundamentally as a long liberation formulation, administered in a single intramuscular injection (IM), which is more practical in terms of use. Nevertheless, the unnecessary persistence and the potentially unfavorable action of GnRHa during the luteal phase and early gestation have questioned its use. The recovery of the Hypophysarian function begins only 8 weeks after the single injection of long liberation of triptorelina 3.75 mg. The GnRH antagonist (Cetrotide 0,25 mg) makes the hypofisary inhibition shorter than with the analogues and can prepare similar endometrium characteristics as a natural cycle. The recipients will be assigned randomly to a group of treatment or another.


Condition Intervention Phase
Infertility
Drug: Antagonist GnRH Cetrotide
Drug: Agonist GnRH Acetate Triptoreline
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Resource links provided by NLM:


Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Primary Outcome Measures:
  • clinical pregnancy rate [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • implantation rate [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: January 2007
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Active Comparator
A: Antagonist
Drug: Antagonist GnRH Cetrotide
Cetrotide 0.25 mg. daily/ 7 days
Drug: Agonist GnRH Acetate Triptoreline
Acetate Triptorelina (Agonist GnRH), 3.75 mg. single dose
B: Active Comparator
Agonist GnRH
Drug: Agonist GnRH Acetate Triptoreline
Acetate Triptorelina (Agonist GnRH), 3.75 mg. single dose

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • infertile females with preserved gonadal function
  • ages 18 - 43 years old

Exclusion Criteria:

  • BMI: > 28
  • recurrent miscarriages
  • severe male factor
  • important miomas
  • > 44 years old
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00633347

Contacts
Contact: Carmina Vidal, MD PhD 34963050900 cvidal@ivi.es

Locations
Spain
IVI Valencia Recruiting
Valencia, Spain, 46015
IVI Valencia Recruiting
Valencia, Spain, 46015
Contact: Leslie atkinson, BS, Ms         latkinson@ivi.es    
Principal Investigator: Carmina Vidal, MD PhD            
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, Spain
  More Information

No publications provided

Responsible Party: IVI Valencia ( IVI Valencia )
Study ID Numbers: VLC-CV-1006-02
Study First Received: February 21, 2008
Last Updated: March 10, 2008
ClinicalTrials.gov Identifier: NCT00633347     History of Changes
Health Authority: Spain: Ministry of Health

Keywords provided by Instituto Valenciano de Infertilidad, Spain:
oocyte donation
endometrial preparation

Study placed in the following topic categories:
Genital Diseases, Female
Infertility
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Cetrorelix
Genital Diseases, Male
Hormones

Additional relevant MeSH terms:
Genital Diseases, Female
Infertility
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Cetrorelix
Genital Diseases, Male
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009